To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Certolizumab Pegol Induces Mucosal Healing and Clinical Remission in Crohn's Disease: Presented at UEGW URL: http://www.pslgroup.com/dg/22F33A.htm Doctor's Guide October 21, 2008
By Judith Moser, MD VIENNA, Austria -- October 21, 2008 -- A high proportion of patients with active Crohn's disease benefits from treatment with certolizumab pegol, a pegylated tumour necrosis factor-alpha antibody, according to results from 54 weeks of treatment presented here at the 16th United European Gastroenterology Week (UEGW). "Mucosal healing has been suggested as an important outcome for disease modification in Crohn's disease," explained Professor Xavier Hébuterne, MD, Department for Gastroenterology, University Hospital, Nice, France. The study was the Endoscopic Mucosal Improvement in Patients With Active Crohn's Disease Treated With Certolizumab Pegol (MUSIC) trial, which evaluated the effects of certolizumab pegol on the intestinal mucosa. The results were presented in a poster session on October 20. The single-arm, open-label phase 3B study is the first prospective trial to investigate endoscopic improvement in Crohn's disease with a biologic compound. Dr. Hébuterne and colleagues investigated the effects of the drug in 89 patients with a Crohn's Disease Activity Index (CDAI) of 220 to 450, a Crohn's Disease Endoscopic Index of Severity (CDEIS) score of 8 or greater, and ulcerations in at least 2 segments of the intestine. Certolizumab pegol 400 mg was administered subcutaneously for 54 weeks at weeks 0, 2, and 4, and every 4 weeks from week 8. In patients with loss of response, the 2-week schedule was resumed. The primary endpoint was the CDEIS at week 10. At that time, analysis revealed a highly significant improvement (14.7 vs 8.3; P < .0001). "The proportion of patients with deep ulcerations decreased until week 10, and the proportion of patients with superficial ulcers increased," Dr. Hébuterne reported. Endoscopic response (defined as CDEIS decrease >5) was observed in 61.5% of patients, and endoscopic remission (CDEIS <6) in 42.3%. Complete endoscopic remission (CDEIS <3) was seen in 11.5%. Clinical remission, defined as CDAI 150 or less, was obtained in 46.1% of patients at week 10. "We did not find any correlation between the endoscopic score and the clinical score, but the majority of patients displayed improvement in both outcome measures," Dr. Hébuterne said. Mean CRP levels showed a rapid decrease within 2 weeks of treatment initiation and stayed at a low level. Again, there was no correlation between the CRP change from baseline and the CDEIS. Drug-related adverse events occurred in 42% of patients and serious adverse events in 13%. There were no new safety signals, according to the researchers. Treatment-emergent events with onset prior to week 10 included infections (such as abdominal abscess), fungal infections, and nasopharyngitis (1.1% each). "The follow-up will allow us to assess prospectively the effect of mucosal healing on the clinical outcomes," Dr. Hébuterne said. [Presentation title: Endoscopic Improvement in Patients With Active Crohn's Disease Treated With Certolizumab Pegol: First Results of the MUSIC Clinical Trial. Abstract OP073] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.